Are you looking for a patient-focused company that will inspire you and support your career? If so, be empowered to take charge of your future at Takeda. Join us as a Senior Scientific Manager, Analytical Development, Pharmaceutical Sciences Cell Therapies in our Cambridge office.
Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As a Senior Scientific Manager in the Pharmaceutical Sciences Cell Therapies team, you will be empowered to build our Cell Therapy footprint, and execute our strategy.
The Senior Scientific Manager of Analytical Development will execute strategic plans for the build out of a world-class cell therapy analytical development and product characterization group. The position will coordinate with other departments and manage daily operations in support of company goals and driving objectives to completion.
The position will be a subject matter expert in the characterization of CAR T-cells, other genetically modified immune cells, stem cells, and other advanced cell therapy products. The position will manage the analytical laboratory daily operations and a group of analytical scientists to ensure that laboratory activities are well coordinated, analytical methods are qualified and fit for purpose, and information is effectively communicated and documented. The position will also mentor staff members, foster a spirt of team work, and help the staff grow technically and professionally.
The position will also partner with Manufacturing and Quality groups in the implementation and qualification of analytical methods used for routine QC testing and characterization of therapeutic products, starting materials, and in-process samples. This will include actively managing method transfer, troubleshooting, interpretation of results, and providing technical input for method qualification and validation.
The position will work with research to support pre-clinical activities in the development of new analytical methods. This position will also interact with external collaborators and internal research teams examining clinical samples and outcomes and correlating therapeutic product critical quality attributes.
The key objectives are:
Buildout the Analytical Development capability:
Team buildout support activities associated with hiring and training/cross-training of analytical staff with a mix of technical skills including flow cytometry, genetic characterization, protein characterization, and development of cell based assays
Laboratory buildup provide input into instrument selection; lead activities in the lab for method development and qualification
Lab operations lead the set-up of laboratory SOPs and tools for managing activities, planning experiments, managing and analyzing data, communicating information, and documenting results
Work with the CMC team in successful execution of cell therapy programs:
By being actively engaged in daily operations, manage staff focused on product characterization and testing for early specific cell therapy programs. Ensure that methods are fit for purpose, interpreted correctly, and reported clearly.
Provide technical oversight for the development and qualification of analytical methods used to characterize and test complex products with consideration to automation, high-throughput methods, cost effectiveness, and rapid turn-around of results.
Lead tech transfer activities between analytical development with outside collaborators, CMOs, and testing laboratories
Participate on multi-disciplinary project team and report-out/manage progress towards project deliverables; proactively identify bottlenecks and champion solutions to overcome obstacles.
Participate in generating written CMC content necessary for IND and other regulatory submissions; ensure that CMC content is well integrated, consistent, and technically sound
Mange the integration of analytical methods into routine use in development and manufacturing to permit robust cell therapy processes with rapid feedback on product quality and critical process parameters
Design and develop analytical methods in collaboration with academic and biotech partners; partner with them in the successful execution of research and manufacturing projects.
Collaborate with outside biotech companies, suppliers, academic groups, and C(D)MO partners:
Work collaboratively to advance technology development and novel manufacturing solutions
Seek out and create opportunities for team members to participate in conferences and other learning opportunities
Promote the reputation of the organization as a leader in the cell therapy field through participation in technical conferences
- Accountable project execution, hiring, training, staff assignment, coaching, mentoring and performance management.
- Accountable for specific project elements as assigned in analytical development for product testing and characterization.
- Responsible for the successful transfer of early phase analytics from biotech and academic partners or internal programs.
- Accountable for Cell Therapy CMC content to enable and deliver IND and BLA filings.
- Responsible for managing expenses within budget
EDUCATION, EXPERIENCE, BEHAVIOURAL COMPETENCIES AND SKILLS:
- Advanced degree (MS or PhD) in relevant scientific discipline (such as Biotechnology, Immunology, Molecular Biology, Biochemistry), and prior experience in analytical/QC testing and characterization of cell and gene therapy products
- Minimum 5 years of relevant experience in leadership and people management with successful performance track record. Experience in technical development of biologics and other advanced modalities in early and late development setting is highly desirable.
- Excellence and successful track record in managing interfaces with other functions and integrated teams.
- Relevant experience in cell and gene therapies CMC teams including experience on product development teams
- Proven track record and demonstrated success in analytical development.
- Strong leadership skills and strategic problem-solving ability; ability to predict issues and identify solutions.
- Ability to lead successfully within extended, global multinational project teams and handle multiple challenges under pressure.
- Demonstrated ability for innovative and big picture thinking.
- Requires the flexibility and tolerance to best manage change and differing opinions with diplomacy and competence.
- Excellent communications and presentation skills written and verbal; create and deliver presentations with appropriate messaging and focused recommendations
- Excellent organizational skills: Proactive, management of multiple tasks of varied complexity simultaneously
- Negotiation and strong persuasive abilities, diplomacy and positive influencing abilities
- Fluent in English
- Must be willing to occasionally work weekends or be on call if required by project demands and manufacturing facility needs
- Occasional travel is required.
- Domestic and international flights with overnight stays required
WHAT TAKEDA CAN OFFER YOU
- 401(k) with company match and Annual Retirement Contribution Plan
- Tuition reimbursement
- Company match of charitable contributions
- Health & Wellness programs including onsite flu shots and health screenings
- Generous time off for vacation and the option to purchase additional vacation days
- Community Outreach Programs
Empowering Our People to Shine
Learn more at takedajobs.com
No Phone Calls or Recruiters Please.